Do I Need a Notified Body? Modules A to H, Law by Law

What is a notified body?

A notified body is an organisation that carries out third-party conformity assessment under one or more EU product laws. The authority of a Member State designates it after checking its competence, independence and impartiality. That authority then notifies it to the European Commission and the other Member States, which is where the name comes from.

Each notification covers specific laws, specific modules and specific product types. Outside that scope, the body has no authority to act as a notified body. Notified bodies can be private or public organisations, and you pay them for their services. Whatever the body concludes, the manufacturer remains responsible for compliance.

Conformity assessment modules A to H explained

Conformity assessment shows that a product meets the essential requirements before it is placed on the market. Every procedure looks at two moments: the design phase and the production phase. Decision No 768/2008/EC provides a menu of procedures, called modules, in its Annex II. Each EU law then picks the modules that fit the risk of its products.

• Module A, internal production control: the manufacturer does everything alone. No notified body. In A1 and A2, a notified body (or an accredited in-house body where the law allows it) supervises tests or checks products at random intervals.
• Module B, EU-type examination: a notified body examines the technical design and issues an EU-type examination certificate. It covers design only, so it is never used alone.
• Modules C, D, E and F cover production after module B. In C the manufacturer controls production alone; C1 adds supervised product testing and C2 adds random product checks. In D and E a notified body approves the quality system for production or for final inspection and testing. In F it verifies the products themselves.
• Module G, unit verification: a notified body examines one specific unit and certifies that unit only.
• Module H, full quality assurance: a notified body approves and monitors the quality system for design, production, inspection and testing. H1 adds an EU design examination certificate.

The combinations you will meet most often are B+C, B+D, B+E and B+F. The law fixes the menu, and within it the manufacturer chooses. A small company without a certified quality system may prefer B+C. A large company with many variants may prefer module H, so that one approval covers its whole range. The choice affects cost, lead time and how often a notified body visits you.

Do I need a notified body? Law by law

Every EU product law has an article on conformity assessment procedures. That article is your starting point. The table below summarises the main laws exporters meet. Always read the article in the latest consolidated version of the law.

Low voltage, RoHS and EMC

Under the Low Voltage Directive (LVD) and RoHS, the manufacturer prepares the technical documentation, carries out the assessment and signs the declaration alone. If someone tells you a notified body must certify your low-voltage product, ask which article says so. Under the EMC Directive, most manufacturers use module A with harmonised standards. In the B+C route, a notified body examines the technical documentation and the EMC assessment without testing a specimen. This can help when no harmonised standard fits your product well. See our EMC Directive course for more.

Radio Equipment Directive

For health, safety and EMC under Article 3(1) of the Radio Equipment Directive (RED), module A is always possible. For the radio and other requirements of Article 3(2) and 3(3), including cybersecurity, module A is possible only if you fully apply harmonised standards that cover them, with references published in the Official Journal. If a citation restriction matters for your product, you apply standards only in part, or no standard exists, you must use B+C or H with a notified body.

This has become very practical since 1 August 2025, when Delegated Regulation (EU) 2022/30 started to apply cybersecurity requirements to many radio products. The harmonised standards are the EN 18031 series, currently cited with restrictions. Read the citation itself and check the latest position in the Official Journal. Our RED cybersecurity course covers this in depth.

ATEX and pressure equipment

ATEX procedures depend on the equipment category:

• Category 1 and M1: B+D or B+F.
• Category 2 and M2 electrical equipment and internal combustion engines: B+C1 or B+E.
• Other category 2 equipment, mostly non-electrical: module A, plus lodging the technical documentation with a notified body, which acknowledges receipt and keeps it.
• Category 3: module A.

Module G is also allowed for all categories. Protective systems and some other devices have their own rules. Under the Pressure Equipment Directive (PED), you calculate the category from the type of equipment, maximum allowable pressure, volume or nominal size and fluid group. Category I uses module A. From category II upwards a notified body is always involved. Equipment below the lowest threshold falls under sound engineering practice and gets no CE marking under this directive.

Do I need a notified body for machinery?

The date of placing on the market decides which law applies to each unit. Machines placed on the market up to 19 January 2027 follow Directive 2006/42/EC. From 20 January 2027 they follow Regulation (EU) 2023/1230. For machinery, electrical hazards are covered by the machinery law, so there is no separate LVD assessment.

Under the Directive, machinery outside Annex IV uses the internal check of Annex VIII, with no notified body. Annex IV machinery may use Annex VIII only when harmonised standards fully cover all relevant essential health and safety requirements. Otherwise you need EC type-examination (Annex IX) or full quality assurance (Annex X).

Under the Regulation:

• Annex I, Part A: a notified body is always required, even with harmonised standards applied in full. Options are B+C, H or G.
• Annex I, Part B: module A only if you fully apply harmonised standards or common specifications covering all relevant requirements. Otherwise B+C, H or G.
• All other machinery, the large majority: module A.

Annex I of the Regulation is not a copy of Annex IV of the Directive, so do not assume your result stays the same. Partly completed machinery does not carry the CE marking under the machinery law and involves no notified body. Our Machinery Regulation 2023/1230 guide explains the changes.

How to find and choose a notified body in NANDO

All notified bodies are listed in NANDO, a public database of the European Commission. You can search by legislation, by country or by body. For each body, NANDO shows the legislation, the modules and the products it may assess. It also shows notifications that have been suspended or withdrawn. A certificate issued outside the notified scope will not support your declaration of conformity.

Notified bodies are usually located in the EU or the European Economic Area (EEA). Bodies from some countries with specific agreements with the EU, such as Türkiye, can also appear in NANDO for certain laws. The rules differ by agreement and by law, so check NANDO rather than assume. When choosing, consider:

1. Scope: your legislation, module and product must be in its NANDO entry.
2. Experience with products like yours.
3. Language: it must read your documentation, and you must understand its reports.
4. Lead time and availability for audits or tests.
5. Coverage: one body notified for all the laws you need can simplify the project.

Ask for a written quotation listing every step, including tests, audits, travel and certificate maintenance. A notified body must be impartial. It cannot design, manufacture, install or maintain the product it assesses, and it cannot give consultancy on making that product compliant.

What does a notified body issue?

Under module B, a notified body issues an EU-type examination certificate for the design. Under quality assurance modules such as D, E or H, it issues a quality system approval, followed by periodic surveillance audits. Under module G, it issues a certificate of conformity for the single unit it verified. Many of these documents have an expiry date. If you change the product, tell the body, because some changes need a new examination.

The Commission gives each body a four-digit number. When the body takes part in the production phase, that number follows the CE marking, for example CE xxxx. With B+C, where the body acts only in the design phase, the number does not follow the CE marking. The declaration of conformity always names the body involved.

There is no "CE certificate" for a product that follows module A. The only document declaring compliance is the manufacturer's EU Declaration of Conformity. Some bodies issue voluntary certificates outside the legal procedures. These do not replace the procedure required by law and do not transfer responsibility from the manufacturer. The CE Marking Fundamentals course covers conformity assessment in its Module 4.

Key points

• Each EU law sets its allowed modules; the manufacturer chooses within that menu.
• LVD and RoHS use module A only; most EMC products also use module A.
• Under the RED, harmonised standards applied in full and without a relevant restriction decide whether module A is possible for Article 3(2) and 3(3).
• Higher ATEX and PED categories, and machinery in Annex I Part A, need a notified body.
• Check the body's scope in NANDO before you sign a contract.